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WO2014089366A2 - Appareil et procédés d'ancrage de dispositif médical - Google Patents

Appareil et procédés d'ancrage de dispositif médical Download PDF

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Publication number
WO2014089366A2
WO2014089366A2 PCT/US2013/073429 US2013073429W WO2014089366A2 WO 2014089366 A2 WO2014089366 A2 WO 2014089366A2 US 2013073429 W US2013073429 W US 2013073429W WO 2014089366 A2 WO2014089366 A2 WO 2014089366A2
Authority
WO
WIPO (PCT)
Prior art keywords
plate member
plug portion
slot
anchoring
engagement surfaces
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2013/073429
Other languages
English (en)
Other versions
WO2014089366A3 (fr
Inventor
Bruce A. Behymer
Eric H. Bonde
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2014089366A2 publication Critical patent/WO2014089366A2/fr
Publication of WO2014089366A3 publication Critical patent/WO2014089366A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0539—Anchoring of brain electrode systems, e.g. within burr hole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/347—Locking means, e.g. for locking instrument in cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/302—Surgical robots specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B2090/103—Cranial plugs for access to brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition

Definitions

  • the present disclosure pertains to medical devices and more particularly to various apparatus, assemblies and methods for anchoring an elongate medical device within a body portal, for example, a burr hole formed in a skull of a patient.
  • Medical procedures for treating a variety of neurological conditions require access to the brain, typically through a burr hole formed in the skull, for the insertion of deep brain stimulating electrodes. Burr holes may also be formed for the insertion of a delivery catheter, for example, to provide drug therapy for similar conditions.
  • Stereotactic apparatus and procedures which are known to those skilled in the art, may be employed by surgeons to locate inserted electrodes and/or drug delivery ports in target regions of the brain.
  • Figure 1A is a perspective view of an exemplary stereotactic guidance system 100
  • Figure 1A illustrates a ring 120 of guidance system 100, which extends around a perimeter of a burr hole 1 1 formed in the skull, supporting a socket assembly 140 to which a micropositioning drive 160 is attached.
  • Burr hole 1 1 may be lined with a base ring 112 ( Figure 1 B; e.g. the Medtronic Stimioc base) that is mounted around burr hole 11 prior to attaching ring 120 of guidance system 100.
  • Figure 1 further illustrates an elongate medical device 15, for example, a medical electrical lead carrying one or more stimulating electrodes, held within drive 160 for advancement through burr hole 1 1 and into the target region of the brain.
  • Figure 1 B illustrates a portion of the implanted device 15, after guidance system 100 is removed, extending proximally out from base ring 1 12, which lines burr hole 1 1 , and which is fastened to the skull, for example, via screws received through holes 106 in base ring 112.
  • a proximal portion of implanted device 15, outside the cranial space may be routed, beneath the scalp and subcutaneously, to a therapy generator (not shown), for example, implanted in proximity to the clavicle.
  • Figure 1 B further illustrates device 15 extending through a slot of base ring 1 12 so that device 15 may be secured/anchored between base ring 1 12 and a cap that snaps into place thereover (not shown; e.g., the Medtronic Stimloc cap).
  • a cap that snaps into place thereover (not shown; e.g., the Medtronic Stimloc cap).
  • Figure 1 A is a perspective view of an exemplary stereotactic guidance mounted to a patient's skull
  • Figure 1 B shows an exemplary base ring mounted in a burr hole of the skull
  • Figures 2A-B are perspective views of an anchoring apparatus, according to some embodiments
  • Figure 2C is an elevation view of an anchoring apparatus, according to some embodiments
  • Figure 2D is a perspective view of an anchoring apparatus, modified from that shown in Figures 2A-B, according to some embodiments;
  • Figure 2E is a perspective view of a cap, which may be employed with the apparatus of Figure 2D, according to some embodiments;
  • Figure 3A is a perspective view (partially transparent) of an anchoring apparatus, according to some embodiments;
  • Figures 3B-C are a top plan view and a cross-section view of the apparatus shown in Figure Figure 3D is a perspective view of an anchoring apparatus, according to some alternate embodiments;
  • Figure 3E is a bottom plan view of the anchoring apparatus shown in Figure 3D, according to some embodiments.
  • FIGS 4A-B are perspective views of an anchoring assembly, according to yet further embodiments.
  • Figure 4C is a perspective view of an anchoring apparatus, modified from that shown in Figures 4A-B, according to some embodiments.
  • Figure 5 is a flow chart outlining some methods of the present invention.
  • Embodiments of anchoring apparatus and assemblies are suitable for mounting/fixing in or over a body portal, for example, a cranial burr hole, in order to anchor in place an implanted elongate medical device, such as an electrical lead or a fluid delivery catheter, which is implanted in the body via insertion through the body portal.
  • the apparatus and assemblies include various configurations of spring biased engagement surfaces, which may be retained in an open position while the elongate medical device is positioned therebetween, either before or after the apparatus/assembly is fixed relative to the body portal.
  • Associated methods for employing the various apparatus and assemblies are disclosed in conjunction with the detailed description of each exemplary embodiment thereof, and in summary at the end of the detailed description.
  • Figures 2A-B are perspective views of an anchoring apparatus 700, according to some embodiments.
  • Figures 2A-C illustrate apparatus 700 including a central, or plug portion 70 and ring member 710, which extends around a perimeter of plug portion 70; a siot 713 extends from an opening thereof, formed through ring member 710, between outer and inner perimeter surfaces 740, 720 thereof, and into plug portion 70.
  • Figures 2A-B further illustrate plug portion 70 including spring biased opposing engagement surfaces 735 that form opposing sides of slot 713, wherein opposing sides of slot 713 are defined by opposing arms 731 , 732 of a spring member 730 of plug portion 70.
  • Spring member 730 is shown including a fixed end 734, which is coupled to inner perimeter surface 720 of ring member 710, and from which each of a pair of opposing arms 731 , 732 extends to a corresponding moveable end 707, 708 thereof.
  • each of first and second moveable ends 707 each of first and second moveable ends 707,
  • Plug portion 70 is shown including an optional ledge 721 that extends around inner perimeter surface 720 of ring member 710; if included, ledge 721 preferably extends in proximity to each end 701 , 702 of ring member 710, at the opening of slot 713, to support ends 707, 708 of spring member
  • anchoring apparatus 700 further includes a retaining member, for example, a pin-like tool 715, which is shown inserted between arms
  • lead 15 is implanted through the body portal/burr hole 1 1 , for example, via the above described guidance system 100 ( Figure 1A), lead 15 is positioned between engagement surfaces 735, and then, with reference to the elevation view of Figure 2C, an outer perimeter surface of plug portion 70, which extends below ring 710, and which is defined by press fit features 78, is press fit within burr hole 1 1. Subsequently, retaining member/tool 715 may be removed, per arrow Y, to allow/ arms 731 , 732 of spring member 730 to move together according to the spring bias thereof, thereby anchoring lead 15 between engagement surfaces 735, as illustrated in Figure 2B.
  • a proximal portion of lead 15 may be received in one of channels 714, which are formed in ring member 710, and may guide routing of the proximal end of lead 15 to another site in the body for connection to a therapy generator.
  • Figures 2A-B further illustrate outer perimeter surface 740 of ring member 710 having fastening features extending therefrom, wherein the fastening features include holes 706 through which screws may be inserted for fastening the press fit anchoring apparatus 700 to the skull surrounding burr hole 1 1 , for example, prior to removing the retaining member to anchor lead 15.
  • apparatus 700 may be positioned around a delivery catheter 105, which extends from the body portal/burr hole 1 1 , after which plug portion 70 may be press fit within hole 1 1 , and retaining member/tool 715 removed to temporarily hold catheter 105 in place while a device, such as lead 15, is delivered therethrough for implant. Then, once lead 15 is implanted, catheter 105 is withdrawn, over lead 15, out from hole 1 1 , and from between arms 731 , 732, to allow engagement surfaces 735 to move together, according to the spring bias of arms 731 , 732, and, thereby anchor lead 15.
  • a delivery catheter 105 which extends from the body portal/burr hole 1 1 , after which plug portion 70 may be press fit within hole 1 1 , and retaining member/tool 715 removed to temporarily hold catheter 105 in place while a device, such as lead 15, is delivered therethrough for implant. Then, once lead 15 is implanted, catheter 105 is withdrawn, over lead 15, out from hole 1 1 , and from between arms 731 ,
  • a distance between arms 731 , 732 in a spring biased closed position, without lead 15 or any retaining member positioned therebetween, is preferably less than a diameter of lead 15, for example, a distance of approximately 0.040 inch when the lead diameter is approximately 0.055 inch; this interference condition combined with the material properties of spring member 730 defines a holding force.
  • Spring member 730 may be integrally formed with ring member 210, for example, by injection molding, from a biocompatible polymer material, such as polyurethane, polycarbonate, polysuifone, polyether ether ketone (PEEK), or nylon. Alternately, spring member 730 is formed as a separate part, wherein end 734 is subsequently attached to ring member 710 along inner perimeter surface 720, as shown.
  • spring member 730 is formed from a relatively high durometer polyurethane, and ring member 710 from a relatively low durometer polyurethane, and then member 730 and ring 710 are uitrasonicaliy welded, or solvent bonded together.
  • spring member 730 may be formed by overmolding a metal core, for example, a stainless steel alloy or nitinol torsional spring, with a biocompatible polymer such as polyurethane.
  • Figure 2D is a perspective view of an anchoring apparatus 300, modified from that shown in Figures 2A-B, according to some embodiments.
  • Figure 2D illustrates apparatus 300 including a central, or plug portion 30 and a ring member 310, which extends around a perimeter of plug portion 30; like apparatus 700, apparatus 300 has slot 713 extending from an opening thereof, formed through ring member 310, and into plug portion 30.
  • Figure 2D further illustrates plug portion 30 including spring biased opposing engagement surfaces 735 that form opposing sides of slot 713, wherein opposing sides of slot 713 are defined by opposing arms 331 , 332 of a spring member 330 of plug portion 30.
  • Spring member 330 is similar to spring member 730 of apparatus 700 in that spring member 330 includes a pair of opposing arms 331 , 332, wherein each arm 331 , 332 extends between a fixed end 334 of spring member 330, which is coupled to ring member 310, and a corresponding moveable end 307, 308; but plug portion 30 of apparatus 300 further includes an elastomer materia! 33, for example, a medical grade silicone rubber, that extends between each arm 331 , 332 and an inner perimeter surface 320 of ring member 310, on either side of slot 713, and is compressed when arms are forced apart, for example, by the above-described retaining member.
  • an elastomer materia! 33 for example, a medical grade silicone rubber
  • elastomer material 33 enhances the spring bias provided by arms 331 , 332 to opposing engagement surfaces 735, and may further enhance sealing of burr hole, when apparatus 700 is press fit therein. Furthermore, with reference to the elevation view of Figure 2C, all or a portion of press fit features 78 may be formed by an extent of elastomer material 33.
  • a distance between arms 331 , 332 in a spring biased dosed position is preferably less than a diameter of the medical device to be anchored between engagement surfaces 735, for example, a distance of approximately 0.040 inch, when a device diameter is approximately 0.055 inch.
  • Spring member 330 may be integrally formed with ring member 310, for example, by injection molding, from a biocompatible polymer material, such as polyurethane, polycarbonate, poiysuifone, polyether ether ketone (PEEK), or nylon. Alternately, spring member 330 is formed as a separate part, wherein end 334 is subsequently attached to ring member 310.
  • spring member 330 is formed from a relatively high durometer polyurethane, and ring member 310 from a relatively low durometer polyurethane, and then member 330 and ring 310 are uitrasonically welded, or solvent bonded together.
  • Methods described above for anchoring an elongate medical device within a body portal, for example, lead 15 in burr hole 1 1 are generally applicable to anchoring apparatus 300. But, according to alternative methods, another type of retaining member may be employed with apparatus 300.
  • each arm 331 , 332 of spring member 330 includes an aperture 305 to mate with a retaining member, for example, a forceps-type tool used to spread arms 331 , 332 apart from one another, while the elongate medical device and/or catheter is inserted between engagement surfaces 735.
  • a retaining member for example, a forceps-type tool used to spread arms 331 , 332 apart from one another, while the elongate medical device and/or catheter is inserted between engagement surfaces 735.
  • a cap 400 is preferably secured in place over plug portion 30.
  • Figure 2D illustrates ring member 310 protruding from an upper surface 312 of plug portion 30, and including a mounting groove 302 and opposing edges 301 , which are located on either side of the opening of slot 713, and which overhang moveable ends 307, 308 of arms 331 , 332.
  • edges 301 and mounting groove 302 provide mating features for cap 400 to cover upper surface 312 of plug portion 30, v/hen an outer perimeter edge 402 of cap 400 is contained within an inner perimeter surface 320 of ring member 310.
  • a first perimeter tab 41 of cap 400 may be inserted beneath the overhang of opposing edges 301 of ring member 310, and a second compressible tab 42 may be compressed, per arrows C, to fit tab 42 within mounting groove 302 of ring member 310.
  • Figure 2E illustrates tab 42 being formed by opposing resilient prongs, each of which includes a protruding feature 422, which is configured to interlock with a corresponding sidewali 342 of mounting channel 302 of ring member 310, according to some embodiments.
  • Figure 3A is a perspective view (partially transparent) of an anchoring apparatus 600,
  • Figure 3B is a top plan view of apparatus 600
  • Figure 3C is a cross-section view through section line A-A of Figure 3B, according to some embodiments.
  • Figures 3A-C illustrate apparatus 600 including a plug portion 680 and a ring member 690, which extends around a perimeter of plug portion 680, wherein plug portion 680 and ring member 690 are preferably integrally formed, for example, from molded medical grade silicone rubber.
  • FIGS 3A-C further illustrate plug portion 680 including a top section 691 , of which ring member 690 is an outward extension, and a bottom surface 693, wherein a first slot 630 extends, between top section 891 and bottom surface 693, from a longitudinally extending opening (spanning a height H of apparatus 600), at an outer perimeter surface of both plug portion 680 and ring member 690, to a longitudinally extending end wall 631 , within plug portion 680.
  • second slot 650 is shown communicating with first slot 630 (best seen in cross-section A-A of Figure 3C), wherein second slot 650 extends from an opening at top section 691 (spanning a width W of apparatus 600) to a radially extending end wall 651 , within plug portion 680.
  • Figure 3C further illustrates an optional channel 697 formed in a lower surface 692 of ring member 690 that projects radially outward from plug 680.
  • a body portal for example, burr hole 11 formed in a skull of a patient
  • Figure 3B illustrates delivery catheter 105 inserted through hole 11 to guide a lead 15, which is contained therein, to a target region of the patient's brain.
  • apparatus 600 may be positioned around catheter 105 and lead 15, per arrow I, such that catheter 105 (shown with dashed lines in Figure 3C) extends in proximity to end wall 631 of first slot 630, after which, plug portion 680 may be press fit into hole 1 1.
  • Figure 3B further illustrates an outer perimeter surface of plug portion 680 being defined by press fit features 608, which facilitate insertion into hole 1 1 and subsequent stability of plug 680 within hole 1 1.
  • a distal end of lead 15 may be passed through catheter 105 and implanted in the target region of the brain, and then catheter 105 withdrawn out from hole 1 1 and apparatus 600, and over lead 15, to leave a segment of the implanted lead 15 captured within slot 630.
  • a more proximal portion of lead 15, which extends outside apparatus 600, may anchor lead within apparatus 600 according to the bold dashed line of Figure 3A.
  • first segment S-1 a segment of lead 15 that extends alongside inner end wall 631 of first slot 830 is designated as a first segment S-1 ; a more proximal segment of lead 15, adjacent to first segment 8-1 , is designated as a second segment S-2, and is shown extending alongside adjacent inner end wall 651 of second slot 650; and a more proximal segment, adjacent to second segment S-2, is designated as a third segment 8-3, and is shown extending around plug 680 in proximity to lower surface 892 of ring member 690, for example, being routed along the aforementioned optional channel 697.
  • lead 15 is anchored with apparatus 600, after inserting first segment S-1 of lead 15 into first slot 630, by bending second segment S-2 into second slot 650, and then wrapping third segment S-3 around plug 680, adjacent to, and beneath the radial projection of ring member 690.
  • Figure 3D is a perspective view of an anchoring apparatus 600-V, which is similar to apparatus 600, described above.
  • Figure 3D illustrates apparatus 600-V including a plug portion 680-V and a ring member 690-V, which are preferably integrally formed, for example, from a molded medical grade silicone rubber, and wherein ring member 690-V is an outward extension of a top section 691-V of plug portion 680-V.
  • Apparatus 600-V like apparatus 600, has first slot 630 extending from an opening, at the outer perimeter surfaces of ring member 690-V and plug portion 680-V, to longitudinally extending end wall 630 within ring member 690-V and plug portion 680-V, as best seen in the bottom plan view of Figure 3E; wherein first slot 630 communicates with a second slot 650-V, which extends from an opening at top section 691-V to a radially extending end wall 651 -V within plug portion 680-V.
  • Apparatus 600-V differs from apparatus 600 in that opposing sides 65 of second slot 650-V open out from one another, for example, to enclose an angle ⁇ (Figure 3E), which is between approximately ten degrees and approximately ninety degrees.
  • lead 15 may be anchored in apparatus 600-V, via segments S-1 , S-2 and S-3 thereof, in a similar manner to that described for apparatus 600, but that outward opening sides 65 of second slot 650-V help to reduce a profile of apparatus 600-V and lead 15, anchored therein, in the area where lead 15 exits apparatus 600-V, which area is designated with reference letter E.
  • Figure 3D illustrates apparatus 600-V including press fit features 608 formed along the outer perimeter surface of plug portion 680-V, similar to plug portion 680, and apparatus 600-V further including fastening features in the form of reinforced holes 606 that are formed through ring member 690-V.
  • holes 606 are configured to receive screws for fastening anchoring apparatus 600-V to the skull surrounding burr hole 1 1 , after plug portion 680-V of apparatus 600-V has been press fit within burr hole 1 1.
  • Such holes 606 may also be included in apparatus 600 of Figures 3A-C, according to some embodiments.
  • Figures 4A-C are perspective views of an anchoring assembly 800, according to yet further embodiments, wherein embodiments of opposing engagement surfaces are formed in an aperture 813 of a plate member 810.
  • Figures 4A-B illustrate assembly 800 including a pair of relatively thin plate members 870, 810 positioned adjacent one another so that a second side 878 of first plate member 870 faces a first side 816 of second plate member 810.
  • Plate members 870, 810 may be formed from titanium or a stainless steel alloy.
  • a nominal thickness of each plate member 870, 810 may be approximately 1 mm, and the extent of each plate member 870, 810 is, preferably, slightly curved, according to some embodiments, for example, to conform to a contour of a skull when secured thereto, as will be described in greater detail below.
  • Figures 4A-B further illustrate an inner perimeter edge 872 of first plate member 870 defining an opening that extends therethrough, from a first side 876 to second side 878, and securing/fastening features 808 of first plate member 870 located in proximity to an outer perimeter edge 874 thereof.
  • Each securing feature 808 is shown including a hole through which a screw/bone fastener may be inserted to secure first plate member 870 over a body portal; and each securing feature 808 is shown projecting from second side 878 of plate member 870 by a distance d.
  • a nominal thickness t of second plate member 810 is less than or approximately equal to distance d so that, when first plate member 870 is secured to a surface surrounding the body portal, for example, burr hole 11 , second plate member 810 may fit within the "standoff" between first plate member 870 and the surface.
  • Figures 4A-B further illustrate second plate member 810 including an anchoring aperture 813 that is formed therethrough, from first side 816 to a second side 818 thereof, wherein aperture 813 has opposing engagement surfaces 81 spring biased toward one another to give aperture 813 a relaxed diameter that is less than an outer diameter of a device to be anchored therein, for example, lead 15 ( Figure 4C).
  • Engagement surfaces 81 may be force to expand from the relaxed diameter, for passage of the device therethrough, for example, via insertion of a delivery catheter through aperture 813, wherein the delivery catheter has a lumen to receive passage of the device therethrough. Once the catheter is removed from around the device, engagement surfaces 81 move back toward one another, according to the spring bias, to anchor the device in aperture 813.
  • aperture 813 is integrally formed in plate member 810 as a dimple spring clip, but, according to an alternate embodiment shown in Figure 4C, opposing engagement surfaces of anchoring aperture 813 are formed by an elastomer insert 850, for example, a silicone grommet.
  • second plate member 810 has a shape, defined by an outer perimeter edge 814 thereof, which, in addition to the aforementioned thickness of second plate member 810, allows second plate member 810 to be captured between secured first plate member 870 and the body portal, such that anchoring aperture 813 is located within a boundary of the opening defined by inner perimeter edge 872, while each securing feature 806 of second plate member 810 is located outside a boundary- defined by outer perimeter edge 873 of first plate member 870.
  • FIG. 5 is a flow chart outlining some methods of the present invention, for example, that employ any of the above-described embodiments of anchoring apparatus and assemblies.
  • an elongate medical device for example, the above described lead 15, may be inserted between opposing engagement surfaces of an anchoring apparatus, per step 510, after the device has been positioned at a target location
  • the anchoring apparatus includes engagement surfaces formed by opposing sides of a slot, like those embodiments described above in conjunction with Figures 2A-3E.
  • the anchoring apparatus is fixed to the body, for example the skull surrounding cranial burr hole 1 1 , per step 515, and then a retaining member, which has held the opposing engagement surfaces apart from one another, against a spring bias thereof, is removed from between the engagement surfaces of the apparatus, per step 530, so that the spring bias moves the engagement surfaces toward one another and into contact with the inserted device.
  • the retaining member may be a separate tool, which extends between the engagement surfaces alongside the inserted device, for example, tool 715 of Figure 2A, or a delivery catheter within which the device is received for positioning at the target location, for example, catheter 105 of Figure 3B.
  • the anchoring apparatus is fixed to the body, per step 515, and then, following path B, the device is positioned between the opposing engagement surfaces thereof, which are held apart by the retaining member, per step 510.
  • first plate member 870 is secured to the body to capture second plate member 810 over the body portal, after which a delivery catheter, as the retaining member, is inserted through anchoring aperture 813 of second plate member 810, so that the device may be positioned between the engagement suifaces of anchoring aperture 813 via passage through the inserted catheter.
  • a position of the captured second plate member 810 over the body portal may be adjusted during the insertion of the catheter and the passage of the device through the catheter, before securing second plate member 810 to the body and moving on to step 530.
  • step 550 the anchoring of device is completed, for example, by routing a proximal segment of the device into a channel, or another slot, of the anchoring apparatus. In some cases, following routing, a cap is secured over the anchoring apparatus.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
  • Electrotherapy Devices (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne des procédés et un appareil pour ancrer un dispositif médical allongé dans un portail corporel, par exemple, un fil de stimulation dans un trou fraisé crânien, lesquels procédés et appareil utilisent des surfaces de mise en prise opposées, sollicitées par ressort l'une vers l'autre. Un élément de retenue peut être introduit entre les surfaces opposées pour maintenir les surfaces espacées pour positionner initialement le dispositif entre elles. Par exemple, un cathéter de pose, dans lequel le dispositif se déplace à travers le portail corporel, peut servir d'élément de retenue, dans un type d'appareil, les surfaces de mise en prise sont formées dans une ouverture d'ancrage d'un élément de plaque d'une paire d'éléments de plaque. Dans un autre type d'appareil, les surfaces de mise en prise sont formées par des côtés d'une fente qui s'étendent à travers un élément de bague et dans un élément de bouchon, une partie de l'élément de bouchon étant, de préférence, formée par un matériau élastomère, et, dans certains cas, l'ensemble de l'appareil.
PCT/US2013/073429 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical Ceased WO2014089366A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261733584P 2012-12-05 2012-12-05
US61/733,584 2012-12-05
US13/795,490 US9604052B2 (en) 2012-12-05 2013-03-12 Medical device anchoring apparatus and methods
US13/795,490 2013-03-12

Publications (2)

Publication Number Publication Date
WO2014089366A2 true WO2014089366A2 (fr) 2014-06-12
WO2014089366A3 WO2014089366A3 (fr) 2014-09-12

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PCT/US2013/073436 Ceased WO2014089371A2 (fr) 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical
PCT/US2013/073419 Ceased WO2014089360A2 (fr) 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical
PCT/US2013/073429 Ceased WO2014089366A2 (fr) 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical

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PCT/US2013/073436 Ceased WO2014089371A2 (fr) 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical
PCT/US2013/073419 Ceased WO2014089360A2 (fr) 2012-12-05 2013-12-05 Appareil et procédés d'ancrage de dispositif médical

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US (3) US9468751B2 (fr)
EP (1) EP2928546B1 (fr)
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Also Published As

Publication number Publication date
WO2014089371A2 (fr) 2014-06-12
US20140155860A1 (en) 2014-06-05
US9468751B2 (en) 2016-10-18
US9539421B2 (en) 2017-01-10
US20140155859A1 (en) 2014-06-05
WO2014089360A3 (fr) 2014-08-28
WO2014089360A2 (fr) 2014-06-12
WO2014089366A3 (fr) 2014-09-12
WO2014089371A3 (fr) 2014-10-23
EP2928546B1 (fr) 2016-11-09
US20140155909A1 (en) 2014-06-05
EP2928546A2 (fr) 2015-10-14
US9604052B2 (en) 2017-03-28

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